NCT00891228 (CCN007) is a Phase 1 clinical trial of Testosterone in Contraception, sponsored by Premier Research.

Who is sponsoring NCT00891228?

NCT00891228 is sponsored by Premier Research.

What drugs are being tested in NCT00891228?

Interventions in NCT00891228: Testosterone, Nestorone®, Nestorone®, Nestorone®.

What condition does NCT00891228 study?

NCT00891228 studies Contraception.

Is NCT00891228 still recruiting?

NCT00891228 is currently completed. Last updated 26 April 2018.

Are results published for NCT00891228?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-04-26 · How we verify

NCT00891228: CCN007

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multicenter, Randomized, Double-Blind Comparator Trial of the Safety and Sperm and Gonadotropin Suppression Resulting From Combined Use of Nestorone® Gel (0, 8 or 12 mg NES) and Testosterone Gel (10 g) Compared With Testosterone Gel in Normal Men

Completed Phase 1 Results posted Last updated 26 April 2018

What this trial tests

Phase 1 trial testing Testosterone in Contraception in 99 participants. Completed in 1 November 2011.

Timeline

1 May 2009

Primary endpoint
1 May 2010

1 November 2011

Quick facts

Lead sponsor	Premier Research
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	99
Start date	1 May 2009
Primary completion	1 May 2010
Estimated completion	1 November 2011
Sites	2 locations across United States

Drugs / interventions tested

Testosterone (TESTOSTERONE) — full drug profile →
Nestorone®
Nestorone®
Nestorone®

Conditions studied

Contraception — all drugs for Contraception →

Sponsor

Premier Research — full company profile →

Who can join

Adults 18 to 50, male only, with Contraception. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

The Number of Men Who Have Suppression of Sperm Production ≤1Million/mL Million/mL When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel Applied Transdermally.
Time frame: 24 Weeks

Sponsor's own description

To determine the number of men who have suppression of sperm production when using a daily regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel applied transdermally.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Steroid hormones for contraception in men.
Grimes DA, Lopez LM, Gallo MF, Halpern V, et al · · 2012 · cited 5× · PMID 22419294 · DOI 10.1002/14651858.cd004316.pub4

Verify or expand the search:

Other trials of Testosterone

Trials testing the same drug.

NCT07212712 — The Role of Estrogen and Testosterone in Determining Brain Blood Flow and Metabolic Regulation in Humans · NA · not yet recruiting
NCT04675788 — Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening · Phase 4 · completed
NCT06149065 — Factors Associated With the Acne Severity Among Transmen Population: a Cross-sectional Study · completed
NCT02938923 — Starting a Testosterone and Exercise Program After Hip Injury · Phase 3 · completed
NCT05781685 — The Influence of Testosterone on Experimental Pain Perception · EARLY_PHASE1 · completed

Other recruiting trials for Contraception

Currently open trials in the same condition.

NCT07365904 — Investigating Ovulation Inhibition for Use as a Contraceptive · Phase 2 · recruiting
NCT07437495 — Women's Knowledge of Contraception During the Postpartum Period · active not recruiting
NCT06823037 — Hormonal Contraception Access Through Pharmacist Prescribing Implementation · NA · recruiting
NCT07326007 — Verbal Analgesia Versus Standard Technique for Pain Control During Copper T380A Intrauterine Device Insertion in Women W · NA · recruiting
NCT05910580 — Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years · NA · recruiting

Other Premier Research trials

Trials by the same sponsor.

NCT07222228 — A Study to Evaluate the Efficacy and Safety of Subcutaneous Levonorgestrel Butanoate for Female Contraception · Phase 2 · not yet recruiting
NCT04143659 — A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female Contraception · Phase 1 · active not recruiting
NCT03452111 — Study of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception · Phase 2 · completed
NCT03455075 — Study of Spermatogenesis Suppression With DMAU Alone or With LNG Versus Placebo Alone in Normal Men · Phase 2 · completed
NCT03432416 — Study of Efficacy, Cycle Control, and Safety of a NES-E2 Contraceptive Vaginal Ring · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00891228 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Premier Research
Last refreshed: 26 April 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00891228.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing